The Pharma, Biotech and Device Colloquium June 2005 Kaye Scholer llpKaye Scholer llp 0

Mass Tort LitigationMass Tort Litigationv.v.

FDA RegulationFDA Regulation

Jay P. Mayesh

Drug Safety, Product Liability and Litigation

Track II A

June 7, 2005

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FDA Approved DevicesFDA Approved Devices

Dalkon Shield IUD

Artificial Heart Valves

Pacemakers

Pedicle Screws

Silicone Breast Implants

Hip Implants

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Dalkon Shield IUD andSilicone Breast ImplantsDalkon Shield IUD andSilicone Breast Implants

Two (A.H. Robbins and Dow Corning) of the 6 manufacturers of FDA approved devices went bankrupt because of mass

tort liability.

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Artificial Heart Valves, Pacemakers, Pedicle Screws, and Hip Implants

Artificial Heart Valves, Pacemakers, Pedicle Screws, and Hip Implants

Four of the 6 manufacturers of approved devices incurred $$$$$ liabilities.

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The FDA is Your Best Friend

The Courtroom is Your Worst Nightmare

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Welcome To My WorldWelcome To My World

Injured Plaintiffs

Judges

Juries

Evidence

Standard of Proof

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JudgesJudges

Appointed Appointed for LifeElected

(partisan or non-

partisan)

Advisory Committees and FDA Staff

FederalState CourtsFDA

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Judicial Selection in the StatesTable 1: Helland and Tabarrok

Judicial Selection in the StatesTable 1: Helland and Tabarrok

Illinois, MississippiTexas, West Virginia

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Judge Richard NeelyAuthor, The Product Liability MessJudge Richard Neely

Author, The Product Liability Mess

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A Jury of Your PeersA Jury of Your Peers

FDA

• Scientifically educated

• Chosen by merit

• Make decisions based upon known data and reasonable forecast

• Your colleagues

Courtroom

• Scientifically ignorant

• Chosen by lot

• Decisions infected with retrospective bias

• Injured plaintiff “colleagues”

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Juries Do Not UnderstandProof of Cause and EffectJuries Do Not UnderstandProof of Cause and Effect

Association is not cause.

The plural of anecdote is not data.

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“In a world of cause and effect, coincidence is always suspect.”

Dr. Marcia Angell, former Editor In Chief of the New England Journal of Medicine

Juries will not accept chance.

Human nature wants to find a cause.

Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 12

Evidence available to Plaintiffs:Evidence available to Plaintiffs:

Adverse Event Reports

Labeling

Advertising

Marketing

Sales and Profits

Email

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The Pirate and the Hook

Hammers, Ladders, the Garden of Eden

and

Black Box Warnings

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A society obsessed with avoidance of risk embraces the fiction that risk and uncertainty can

be controlled by WARNINGS.

It should have been in a Black Box.

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Jury Charge re FDACompliance is the minimum standard

Jury Charge re FDACompliance is the minimum standard

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Take home message:Take home message:

• Compliance with law is minimum standard.

• Juries may overrule FDA and hold you to a higher standard.

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Get the picture?Get the picture?

The Courtroom is not friendly.

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ProphylaxisProphylaxis

• Do not resist strong warnings suggested by FDA. Strong warnings are your best friend.

• Do not write e-mails you wouldn’t want to see on the front page of the New York Times.

• Prominently include in all DTC advertising the message that all drugs and devices have risks as well as benefits.